510(k) · Cleared
ClearedMicrostaar Msi Injector Foam Tip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Staar Surgical Co. · MSS Folders And Injectors, Intraocular Lens (Iol)
Cleared on Mar 13, 2008 after an 84-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Mar 13, 2008
- Review
- 84 days
- Class
- Class I
- Product code
- MSS
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK073591 Microstaar Msi Injector Foam Tip SystemStaar Surgical Co. · 2008
- Descendant · cites it directly · 3 of its ownK090161 Epiphany Injection SystemStaar Surgical Co. · 2009
- Descendant · 2 generations on · 2 of its ownK101782 Microstaar Msi Injector System CartridgeStaar Japan · 2010
- Descendant · 3 generations on · 0 of its ownK172375 MicroSTAAR Injector System CartridgesSTAAR Surgical Company · 2017
- Descendant · 3 generations on · 0 of its ownK152357 MicroSTAAR Injector System CartridgesSTAAR Surgical Company · 2015
Most influential descendants
Showing 4 of 4 · See all- K090161Epiphany Injection SystemStaar Surgical Co. · 2009 · cites it directly3descendants
- K101782Microstaar Msi Injector System CartridgeStaar Japan · 2010 · 2 generations on2descendants
- K172375MicroSTAAR Injector System CartridgesSTAAR Surgical Company · 2017 · 3 generations on0descendants
- K152357MicroSTAAR Injector System CartridgesSTAAR Surgical Company · 2015 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K073591 | Microstaar Msi Injector Foam Tip System | Staar Surgical Co. | 2008 | — |
| +1 | K090161 | Epiphany Injection System | Staar Surgical Co. | 2009 | — |
| +2 | K101782 | Microstaar Msi Injector System Cartridge | Staar Japan | 2010 | — |
| +3 | K172375 | MicroSTAAR Injector System Cartridges | STAAR Surgical Company | 2017 | — |
| +3 | K152357 | MicroSTAAR Injector System Cartridges | STAAR Surgical Company | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MSS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MSS device
- #1 K261174 RxSight® Insertion Devicescore 15.1 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090161 | Epiphany Injection System | 2009 | 3 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K090161 (Staar Surgical Co., 2009) has gone furthest, with 3 descendants of its own.
How does its category compare?
All MSS devicesMSS Folders And Injectors, Intraocular Lens (Iol): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MSS
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MSS
54in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSS
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MSS
429in 2025
MAUDE reports naming product code MSS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 445 |
| 2008 | 5 | 84 | 0 | 185 |
| 2009 | 5 | 197 | 0 | 186 |
| 2010 | 2 | — | 0 | 203 |
| 2011 | 2 | — | 0 | 95 |
| 2012 | 2 | — | 0 | 129 |
| 2013 | 5 | 141 | 0 | 203 |
| 2014 | 5 | 78 | 0 | 114 |
| 2015 | 3 | 156 | 0 | 127 |
| 2016 | 2 | — | 1 | 112 |
| 2017 | 3 | 30 | 1 | 114 |
| 2018 | 1 | — | 0 | 340 |
| 2019 | 3 | 67 | 0 | 271 |
| 2020 | 2 | — | 0 | 362 |
| 2021 | 1 | — | 0 | 289 |
| 2022 | 0 | — | 0 | 490 |
| 2023 | 3 | 54 | 0 | 330 |
| 2024 | 1 | — | 0 | 375 |
| 2025 | 1 | — | 0 | 429 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The MicroSTAAR TM MSI Injector Foam Tip System is a device intended to fold and insert STAAR Surgical one and three piece Collamer® lenses for surgical placement in the human eye.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K073591 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073591: Microstaar Msi Injector Foam Tip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073591
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026